Posted by Rob Packard
This article is the first part of a two-part case study providing an overview of the pre-market notification process (i.e., 510k Submission) in order to obtain clearance from the US FDA for marketing a new medical device. This first part of the series focuses on the initial steps of a 510k submission project: 1) identifying product classification, 2) identifying any applicable international standards and special controls guidance documents, and 3) selecting a primary predicate device.
For this case study, I chose the maker of Krazy Glue® as a hypothetical new client. The company wants to start selling cyanoacrylate as a topical adhesive in the U.S. market. As with the Canadian and European markets, the US FDA considers cyanoacrylate a medical device when it is used as a topical adhesive. The first step toward obtaining FDA clearance for marketing the new product is to determine the device’s classification.
Device Classification
My client was considering asking the FDA to identify the classification of topical adhesives using the 513(g) submission process, but I provided the following reasons why the client should not use the 513(g) process:
- the 513(g) process takes 60 days to get a response from the FDA, while a qualified consultant can make the same determination in less than a day
- hiring a consultant typically costs less than the 513(g) fee (i.e., $3,387 for large companies and $1,694 for small businesses)
- the FDA’s classification determination is non-binding and the accuracy of the FDA’s response is highly dependent upon the quality of information provided by the company
In this case, I was able to answer the client’s question about device classification over the phone without any charge. The client indicated that they wanted to launch a product similar to Surgiseal. I was able use the US FDA Registration and Listing Database to identify the product classification simply by typing “Surgiseal” in the field for “Proprietary Name.” Adhezion Biomedical LLC is registered as the manufacturer of Surgiseal. The three-letter product code “MPN,” and the device is a Class II device requiring premarket notification via a 510k submission.
This product classification also gives my client additional options that are not available to all companies that are trying to achieve 510(k) clearance for the first time. Most new products can only achieve initial 510(k) clearance from the US FDA by submitting a “traditional” 510(k). This process is supposed to take 90 days—assuming there are no significant questions about the submission and the reviewer has a manageable workload to review. The average time for determination of 510k clearance is currently between 120 and 180 calendar days.
Applicable International Standards & Special Controls Guidance
